Looking to join a world leader in delivering Automation, MES and Digital Transformation solutions to Life Sciences. This is a full-time, permanent position based in Cork.
- Manage Computer System Validation projects from software install to business release
- Generate computer system validation documentation in accordance with site procedures and GMP guidelines
- Execute test scripts, analyse test results and determine the acceptability of results against pre-determined criteria
- initiate and implement Change Control activities in accordance with Quality Standards and Practices
- Determine solutions or recommendations for changes and/or process improvements
- Minimum 3-5 years’ experience validating IT applications e.g requirements gathering, design documentation, test case development, system & acceptance testing
- Past proven experience engaging business users to ensure that appropriate business needs are clearly defined, communicated and delivered
- Experience of server and workstation platform and working in a Win 10 environment
- Experience of analysing and challenging s/w to identify gaps
- Familiar with Annex 11/21CFR Part 11 requirements, GAMP 5 and data integrity guidelines
If you are interested in discussing this role, please reach out to Louise Whitty on 021 2359140 / firstname.lastname@example.org REF Z785954
Following your application for this specific role, Sigmar may contact you regarding other positions that we feel you may be suitable for. If you do not wish to be contacted about other opportunities please let us know. For further information please refer to the Privacy Statement on our website.